Trial Outcomes & Findings for Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride (NCT NCT04207710)
NCT ID: NCT04207710
Last Updated: 2024-03-04
Results Overview
Number of skin samples that were positive for bacterial growth following treatment with ChloraPrep and then application of a topical refrigerant spray (Gebauer's Ethyl Chloride or Gebauer's Pain Ease), when the area was swabbed and cultured for three days. A sample was considered positive if 1 or more colony forming units were present per swab.
COMPLETED
PHASE4
72 participants
Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.
2024-03-04
Participant Flow
Unit of analysis: patch of skin
Participant milestones
| Measure |
Microbial Growth on Wrists and Lower After Application of Gebauer's Ethyl Chloride or Pain Ease.
An area of skin on the wrist swabbed before and after Chloraprep application, and then each area swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. Bacterial growth prior to and after numbing spray application evaluated, based on number of colony forming units present.
An area of skin on the lower back of an individual's skin swabbed before and after Chloraprep application, and then each area swabbed again after application of Gebauer's Ethyl Chloride topical refrigerant spray. Bacterial growth prior to and after spray application evaluated, based on number of colony forming units present.
An area of skin on the wrist swabbed before and after Chloraprep application, and then swabbed again after application of Gebauer's Pain Ease topical refrigerant spray. Bacterial growth prior to and after spray application evaluated, based on number of colony forming units present.
An area of skin on the lower back swabbed before and after Chloraprep application, and then after application of Gebauer's Pain Ease topical refrigerant spray. Bacterial growth prior to and after spray application evaluated, based on number of colony forming units present.
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|---|---|
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Overall Study
STARTED
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72 288
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Overall Study
Left Wrist: ChloraPrep, Then Gebauer's Ethyl Chloride
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72 72
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Overall Study
Right Wrist: ChloraPrep, Then Gebauer's Pain Ease
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72 72
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Overall Study
Low Back: ChloraPrep, Then Gebauer's Ethyl Chloride
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72 72
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Overall Study
Low Back: ChloraPrep, Then Gebauer's Pain Ease
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72 72
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Overall Study
COMPLETED
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72 288
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age information was not collected as this was irrelevant to the study aims.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Skin samples were swabbed within 20 seconds of Ethyl Chloride or Pain Ease application, and then swabs were cultured for 3 days before checking for the presence of CFU.Number of skin samples that were positive for bacterial growth following treatment with ChloraPrep and then application of a topical refrigerant spray (Gebauer's Ethyl Chloride or Gebauer's Pain Ease), when the area was swabbed and cultured for three days. A sample was considered positive if 1 or more colony forming units were present per swab.
Outcome measures
| Measure |
Wrist, Gebauer's Ethyl Chloride
n=72 Participants
Skin on wrist swabbed before treatment, then following sterilization with Chloraprep, then after treatment with Gebauer's Ethyl Chloride topical refrigerant spray. Samples cultured and evaluated for positive bacterial growth.
|
Lower Back, Gebauer's Ethyl Chloride
n=72 Participants
Skin on lower back swabbed before treatment, then after sterilization with Chloraprep, then after application of Gebauer's Ethyl Chloride topical refrigerant spray. Samples cultured and evaluated for positive bacterial growth.
|
Wrist, Gebauer's Pain Ease
n=72 Participants
Wrist swabbed before treatment, after sterilization with Chloraprep, then after application of Gebauer's Pain Ease. Samples cultured and evaluated for positive bacterial growth.
|
Lower Back, Gebauer's Pain Ease
n=72 Participants
Lower back swabbed before treatment, after Chloraprep, then after application of Gebauer's Pain Ease. Samples cultured and evaluated for positive bacterial growth.
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Presence of Microbial Growth (1+ CFU)
Samples with positive growth after application of ChloraPrep followed by topical refrigerant spray
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2 Number of samples with 1+ CFU
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1 Number of samples with 1+ CFU
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1 Number of samples with 1+ CFU
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1 Number of samples with 1+ CFU
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Presence of Microbial Growth (1+ CFU)
Samples with positive growth after application of ChloraPrep
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1 Number of samples with 1+ CFU
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0 Number of samples with 1+ CFU
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0 Number of samples with 1+ CFU
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2 Number of samples with 1+ CFU
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Presence of Microbial Growth (1+ CFU)
Samples with positive growth before ChloraPrep treatment (positive control)
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68 Number of samples with 1+ CFU
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63 Number of samples with 1+ CFU
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65 Number of samples with 1+ CFU
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49 Number of samples with 1+ CFU
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Adverse Events
Microbial Growth on Wrist After Application of Gebauer's Ethyl Chloride
Microbial Growth on Lower Back After Application of Gebauer's Ethyl Chloride
Microbial Growth on Wrist After Application of Gebauer's Pain Ease
Microbial Growth on Lower Back After Application of Gebauer's Pain Ease
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Research, Department of Anesthesiology
Henry Ford Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place